000			a
999			_c20662 _d20662
003			OSt
005			20240223110031.0
008			240223b xxu||||| |||| 00| 0 eng d
040			_aAIKTC-KRRC _cAIKTC-KRRC
100			_922891 _aPatel, Ghanashyam
245			_aEvaluation of the safety and efficacy of curcuvail® in patients with non-alcoholic fatty liver disease - a prospective randomized, double blind, placebo controlled, parallel group study
250			_aVol.17(3), Jul-Sep
260			_aM P _bBRNSS Publication Hub. _c2023
300			_a218-225p.
520			_aIntroduction: The prevalence of non-alcoholic fatty liver disease (NAFLD) has increased to 38.2%. Curcuminoids hold promise, but curcumin’s clinical use is limited. CurcuVail® improves absorption and effectiveness. This study assesses CurcuVail®’s efficacy, safety, and tolerability in NAFLD patients. Materials and Methods: We conducted a prospective, double-blind, placebo-controlled, and parallel-group study in 30 NAFLD patients. Subjects were assigned at random to receive either CurcuVail® or Placebo. The primary efficacy endpoint was the improvement in fatty liver grading based on liver ultrasound from baseline to day 60. Secondary efficacy endpoints included changes in aspartate aminotransferase (AST) to platelet ratio index (APRI) score, Fibrosis score, controlled attenuation parameter (CAP) score, total cholesterol (TC), and liver enzymes. Results: The demographic data of both groups were identical. The overall mean change in NAFLD grading based on liver USG from baseline to the end of treatment was observed to be ?0.27 ± 0.458 in the test group and ?0.07 ± 0.258 in the placebo group. Remarkable and statistically significant differences were observed between the test and placebo treatment groups from baseline to the end of treatment in various parameters, including mean changes in APRI score (?0.38 ± 0.190 vs. ?0.18 ± 0.286), Fibrosis Score (?0.91 ± 0.364 vs. ?0.17 ± 0.135), and CAP score (?20.67 ± 6.651 vs. ?5.27 ± 3.105). Significant reductions were also observed in mean changes of TC, serum alanine aminotransferase, and serum AST from baseline to the end of treatment. No safety or tolerability issues were reported. Discussion: CurcuVail® was found to improve NAFLD grading, FibroScan® parameters, and biochemical markers associated with NAFLD with a good safety profile. However, longterm investigations are necessary to fully evaluate the clinical efficacy and safety profile of the test product. Conclusion: CurcuVail®, a dietary supplement, was found to be clinically safe and effective in NAFLD subjects after 60 days of administration.
650		0	_94639 _aPHARMACEUTICS
773	0		_dMandsaur B.R. Nahata Smriti Sansthan _tInternational journal of green pharmacy _x0973-8258
856			_uhttps://www.greenpharmacy.info/index.php/ijgp/article/view/3472 _yClick here
942			_2ddc _cAR